Closure Apparatuses and Methods for Ulcers and Irregular Skin Defects

ABSTRACT

Devices, methods, and systems for treating an ulcer or skin defect are disclosed. First and second base panels of a closure device are adhered to first and second sides of the ulcer or skin defect, respectively. Lateral ties couple the first and second base panels together and provide a predetermined separation distance or lateral gap between the inner edges of the panel. The predetermined separation distance or lateral gap is sufficient to treat the most common sized ulcers or skin defects, for example, accommodating an ulcer or skin defect with a minor axis of at most 50 mm. The lateral ties have their ends fixed to one panel and their opposite ends adjustably and reversibly attached to the other panel so that the separation distance can be reduced or adjusted to provide a lateral compressive force to the ulcer or skin defect, thereby promoting healing.

CROSS-REFERENCE

This application claims priority to provisional patent application U.S.Ser. No. 62/725,705, which is incorporated herein by reference in itsentirety. The subject matter of the present application is related tothe subject matter in the following U.S. patent applications: U.S.patent application Ser. No. 13/286,757 (now U.S. Pat. No. 8,323,313),Ser. Nos. 13/665,160, 14/180,524 (U.S. Pat. No. 9,050,086), Ser. Nos.14/180,564, 14/625,366 (U.S. Pat. No. 9,642,621), Ser. No. 15/081,526(U.S. Pat. No. 9,474,529), Ser. No. 15/081,550 (U.S. Pat. No.9,554,799), Ser. No. 15/081,595 (U.S. Pat. No. 9,642,622), Ser. No.15/096,083 (U.S. Pat. No. 9,554,800), Ser. No. 15/130,149 (U.S. Pat. No.9,561,034), and Ser. No. 15/369,293, and Provisional patent applicationU.S. Ser. No. 62/725,705, and PCT Application Nos. PCT/US2015/028066,PCT/US2016/028297, and PCT/US2017/028537, which are incorporated hereinby reference in the entirety.

BACKGROUND

The present disclosure is directed to medical devices, methods, andsystems, particularly for aiding the closure and healing of wounds andincisions, specifically ulcers and irregular skin defects.

Staples and sutures have been in use for many years to close wounds andincisions. Staples and sutures, however, may be less than ideal for usewith certain wounds and incisions, for example, because of theirirregular shape or the concentration of closure forces on certain areasof tissue from the staples or sutures, which may lead to additionalscarring or less than optimal healing. Also, once in place, staples andsutures may be difficult to adjust and reverse, such as whenre-approximation of the edges of the wound or incision (i.e., bringingtogether in good alignment) needs to be adjusted. In many such cases,liquid glue, commonly cyanoacrylate, may be used alone or in combinationwith staples, sutures, simple tape strips, or a mesh placed over thewound or incision. The liquid glue may cure or harden over the wound orincision to hold it in place and at least partially protect it from theexternal environment. Once cured, however, liquid glue can be veryrigid. When exposed to lateral forces, blistering and adhesion loss atthe border of the cured glue and the uncovered skin may result. Thecured glue may also crack, exposing the underlying wound or incision.Hence, improved devices, methods, and systems for aiding the closure andhealing of wounds and incisions may be desired.

SUMMARY

The present disclosure provides improved medical devices, methods, andsystems for aiding the closure and healing of wounds and incisions,specifically ulcers and irregular skin defects.

Disclosed herein are methods for treating an ulcer or skin defect. Anexemplary method comprises the steps of adhering a first panel of aclosure device to skin on a first side of an ulcer or skin defect,adhering a second panel of the closure device to skin on a second sideof the ulcer or skin defect, wherein the first and second panels have aseparation distance between inside lateral edges thereof, the separationdistance being at least 10 mm, and laterally compressing the ulcer orskin defect between the first and second panels, thereby reducing theseparation distance between the inside lateral edges of the first andsecond panels.

The methods disclosed herein may be suitable to treat ulcers and skindefects with a variety of shapes and sizes. The ulcer or skin defect canhave a minor axis of at most 50 mm. The ulcer or skin defect can have aminor axis of at most 40 mm. The ulcer or skin defect can have a minoraxis of at most 30 mm. The ulcer or skin defect can have a minor axis ofat most 20 mm. The ulcer or skin defect can have a minor axis of at most10 mm. The separation distance between the inside lateral edges of thefirst and second panels prior to laterally compressing the ulcer or skindefect can be at least 20 mm. The separation distance between the insidelateral edges of the first and second panels prior to laterallycompressing the ulcer or skin defect can be at least 30 mm.

The method can further comprise removing one or more liners from theclosure device prior to adhering the first and second panels to theskin. The one or more liners can be aligned in an orientation transverseto longitudinal axes of the first and second panels. The method canfurther comprise removing a middle liner prior to adhering the closuredevice to the skin and removing one or more further liners adjacent themiddle liner. The method can further comprise removing one or moreliners adjacent a middle liner prior to adhering the closure device tothe skin and removing the middle liner. The method can further compriseremoving a first liner from the first base panel prior to adhering theclosure device to the skin and removing a second liner from the secondbase panel.

The method can further comprise adhering the first and second panels tothe skin comprises pressing adhesive bottom layers of the first andsecond panels against the skin. The adhesive bottom layers of the firstand second panels can comprise a hydrocolloid adhesive. The first andsecond panels can comprise base layers positioned over the hydrocolloidadhesives, the base layers being more rigid than the hydrocolloidadhesive. The first and second panels each can further comprise one ormore force distribution structures coupled to the base layers, the forcedistribution structures being more rigid than the base layers.

The method can further comprise one or more lateral ties coupling thefirst and second base panels to one another. The one or more lateralties can be at least partially elastic. The one or more lateral ties cancomprise an elastic or spring component. The method can further comprisedisengaging the one or more lateral ties from one or more of the firstor second base panels to provide access to the ulcer or skin defect forcare. The method can further comprise re-engaging the one or morelateral ties to the one or more of the first or second base panels afterthe care. The care can comprise one or more of a cleaning, adebridement, an application of medication, an application of a skinsubstitute, an application of negative pressure, or an application of anoxygen-introducing apparatus to the ulcer or skin defect. Laterallycompressing the ulcer or skin defect can comprise adjusting one or moreattachment points of one or more lateral ties to the first or secondpanels. The ulcer or skin defect can be a diabetic foot ulcer, a venousleg ulcer, an arterial ulcer, a dehisced wound, a dehisced infection, afasciotomy, a pressure or decubitus ulcer, or a biopsy incision.

The method can further comprise adhering the first and second panels ofthe closure device positions the closure device over the ulcer or skindefect in a first orientation, and wherein the method further comprisespositioning a second closure device over the ulcer or skin defect in asecond orientation different from the first orientation and adheringbase panels of the second closure device to the skin on third and fourthsides of the ulcer or skin defect.

The method can further comprise further reducing the separation distancebetween the inside lateral edges of the first and second panels afterthe ulcer or skin defect has at least partially healed. The method cancomprise further reducing the separation distance between the insidelateral edges of the first and second panels after the ulcer or skindefect has at least partially healed comprises incrementally tighteningone or more lateral ties coupling the first and second base panels toone another over a period of time to restore or increase a compressiveforce to promote healing of the ulcer or skin defect.

One or more of the first or second base panels can have a lateralelasticity gradient of increasing elasticity from an inner edge thereofto an outer edge thereof. The lateral elasticity gradient can beprovided by one or more of overlapping materials of differentelasticity, stepped layers of material of a same elasticity, embossing,perforating, or patterning with areas of no material to the one or moreof the first or second base panel. One or more of the first or secondbase panels can have a vertical elasticity gradient of increasingelasticity from an upper surface thereof to a bottom surface thereof.The vertical elasticity gradient can be provided by verticallyoverlapping layers of different elasticity or thickness. One or more ofinner or outer edges of one or more of the first or second base panelscan be sinusoidal or scalloped to minimize or distribute shear force orminimize skin blister formation.

Disclosed herein are closure devices for treating an ulcer or skindefect. An exemplary closure device comprises a first panel having afirst adhesive bottom surface for adhering to skin on a first side of anulcer or skin defect, a second panel having a second adhesive bottomsurface for adhering to skin on a second side of the ulcer or skindefect, a plurality of lateral ties coupling the first and second panelsto one another, the plurality of lateral ties maintaining a separationdistance of at least 10 mm between inside lateral edges of the first andsecond panels, and one or more liners coupled to the first and secondadhesive bottom surfaces.

The separation distance can be at least 20 mm. The separation distancecan be at least 30 mm. The separation distance can be at least 40 mm.The separation distance can be at least 50 mm.

The one or more liners can be aligned in an orientation transverse tolongitudinal axes of the first and second panels. The one or more linerscan comprise a middle liner prior and one or more further linersadjacent the middle liner. The one or more liners can comprise a firstliner removably coupled to the first adhesive bottom layer of the firstbase panel prior and a second liner removably coupled to the secondadhesive bottom layer of the second base panel.

The first and second adhesive bottom layers of the first and secondpanels can comprise hydrocolloid adhesive. The first and second panelscan comprise base layers positioned over the hydrocolloid adhesives, thebase layers being more rigid than the hydrocolloid adhesive.

The first and second panels each can further comprise one or more forcedistribution structures coupled to the base layers, the forcedistribution structures being more rigid than the base layers. The oneor more lateral ties can be at least partially elastic. The one or morelateral ties can comprise an elastic or spring component. The one ormore lateral ties can be at least partially disengagable andre-engagable to provide access to the ulcer or skin defect for care. Theone or more lateral ties can be at least partially adjustable to reducethe separation distance between the inside lateral edges of the firstand second panels and apply a compressive force to tissue therebetweenwhen the device is adhered to skin.

The one or more of the first or second base panels can have a lateralelasticity gradient of increasing elasticity from an inner edge thereofto an outer edge thereof. The lateral elasticity gradient can beprovided by one or more of overlapping materials of differentelasticity, stepped layers of material of a same elasticity, embossing,perforating, or patterning with areas of no material to the one or moreof the first or second base panel. The one or more of the first orsecond base panels can have a vertical elasticity gradient of increasingelasticity from an upper surface thereof to a bottom surface thereof.The vertical elasticity gradient can be provided by verticallyoverlapping layers of different elasticity or thickness. The one or moreof inner or outer edges of one or more of the first or second basepanels can be sinusoidal or scalloped to minimize or distribute shearforce or minimize skin blister formation.

Disclosed herein are closure devices for treating an ulcer or skindefect. An exemplary closure device comprises an adhesive bottom layer,a base layer, a plurality of supports coupled to the base layer; and aplurality of adjustable ties coupled to the plurality of supports,wherein the adhesive bottom layer and the base layer define a centraltreatment aperture to accommodate the ulcer or skin defect, and whereinthe plurality of adjustable ties are adjustable to reduce an area of thecentral treatment aperture and apply a compressive force tissueencompassed by the central treatment aperture thereby.

Each lateral tie can comprise a fixed end and an adjustable end. Thelateral ties can be arranged end-to-end along a periphery of the closuredevice. The fixed ends of the lateral ties can be adjacent adjustableends of the lateral ties. The device can further comprise a central hubstructure. The fixed ends of the lateral ties can be coupled to thecentral hub structure and the adjustable ends of the lateral ties arecoupled to the supports coupled to the base layer.

The bottom layer can comprise a hydrocolloid adhesive. The main layercan be positioned over the hydrocolloid adhesive and is more rigid thanthe hydrocolloid adhesive. The plurality of supports can be more rigidthan the base layers. The one or more lateral ties can be at leastpartially disengagable and re-engagable.

The device can have a lateral elasticity gradient of increasingelasticity from an inner edge thereof to an outer edge thereof. Thelateral elasticity gradient can be provided by one or more ofoverlapping materials of different elasticity, stepped layers ofmaterial of a same elasticity, embossing, perforating, or patterningwith areas of no material to the one or more of the first or second basepanel. The device can have a vertical elasticity gradient of increasingelasticity from an upper surface thereof to a bottom surface thereof.The vertical elasticity gradient can be provided by verticallyoverlapping layers of different elasticity or thickness. The one or moreof inner or outer edges of one or more of the first or second basepanels can be sinusoidal or scalloped to minimize or distribute shearforce or minimize skin blister formation. The device can have atriangular, rectangular, square, pentagonal, hexagonal, or otherpolygonal outer shape.

Disclosed herein are methods for treating an ulcer or skin defect. Anexemplary method may comprise the steps of positioning a closure deviceover the ulcer or skin defect so that the ulcer or skin defect isencompassed by the central treatment aperture of the closure device,adhering the closure device to skin around the ulcer or skin defect, andtightening one or more adjustable ties of the closure device to apply acompressive force to tissue to tissue around the ulcer or skin defectencompassed by the central treatment aperture.

Each lateral tie can comprise a fixed end and an adjustable end. Thelateral ties can be arranged end-to-end along a periphery of the closuredevice. The fixed ends of the lateral ties can be adjacent adjustableends of the lateral ties. The closure device further can comprise acentral hub structure. The fixed ends of the lateral ties can be coupledto the central hub structure and the adjustable ends of the lateral tiesare coupled to the supports coupled to the base layer. The ulcer or skindefect can be a diabetic foot ulcer, a venous leg ulcer, an arterialulcer, a dehisced wound, a dehisced infection, a fasciotomy, a pressureor decubitus ulcer, or a biopsy incision. The ulcer or skin defect canhave a minor axis of at most 30 mm. The ulcer or skin defect can have aminor axis of at most 20 mm. The ulcer or skin defect can have a minoraxis of at most 10 mm.

Wound closure devices described herein may comprise a pair of flexible,adhesive panels placed on opposite sides of the wound or incision.Lateral ties couple the panels together and separate the panels toprovide enough space for the panels to encompass an ulcer or irregularskin defect. Once the closure device is adhered onto the skin adjacentthe ulcer or irregular skin defect, the lateral ties may then betightened to close the separation distance between the panels and applyan inwardly compressive force to promote healing.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the present disclosure are set forth withparticularity in the appended claims. A better understanding of thefeatures and advantages of the present disclosure will be obtained byreference to the following detailed description that sets forthillustrative embodiments, in which the principles of the presentdisclosure are utilized, and the accompanying drawings of which:

Drawing Element Reference Number Closure apparatus  1 Base panel  2aBase panel  2b Force distribution structure elements  3 Lateral tie  4Lateral tie fixed end  5a Lateral tie adjustable end  5b Locks  6Perforations  7 Lateral gap  8 Single base  9 Force distributionstructure 10 Middle layer/main body 11 Release liner 12 Adhesive layer13 Elastic component 14 Open wound 15 Casting sheet 16 Closure element17 Closure element fixed end  18a Closure element adjustable end  18bTab of release liner 19 Wound aperture 20 Central hub structure 21

FIG. 1A shows a top view of a closure apparatus, according toembodiments of the present disclosure.

FIG. 1B shows another top view of the closure apparatus of FIG. 1A.

FIG. 1C shows a side view of the closure apparatus of FIG. 1A.

FIG. 1D shows another top view of the closure apparatus of FIG. 1A.

FIG. 1E shows another top view of the closure apparatus of FIG. 1A,including a wound or incision coverage area.

FIG. 1F shows a top view of the liner of the closure apparatus of FIG.1A.

FIG. 2A shows a top view of a wide closure apparatus, according toembodiments of the present disclosure.

FIG. 2B shows a top view of the wide closure apparatus of FIG. 2A withthe device liner removed.

FIGS. 3A-3F shows a method of applying a closure apparatus to a wound orskin defect, according to embodiments of the present disclosure.

FIG. 3A show a top view of the wound or skin defect.

FIG. 3B shows the closure apparatus with a liner removed.

FIG. 3C shows the closure apparatus with the liner removed placed overthe wound or skin defect.

FIG. 3D shows the closure apparatus with the remaining liners removed;the closure apparatus is pressed and adhered to the skin around thewound or skin defect.

FIG. 3E shows the closure apparatus adhered to the skin and having itslateral ties tightened to apply a lateral compressive force to the woundor skin defect.

FIG. 3F shows a further closure apparatus adhered to the skin around thewound or skin defect and oriented transversely with respect to the firstclosure apparatus.

FIGS. 4A and 4B show top and perspective views, respectively, of aclosure apparatus with flattened lateral edges, according to embodimentsof the present disclosure.

FIGS. 5A and 5B show top and perspective views, respectively, of aclosure apparatus with flattened lateral edges and multi-layered mainpanels, according to embodiments of the present disclosure.

FIGS. 6A and 6B show top and perspective views, respectively, of aclosure apparatus with rounded lateral edges, according to embodimentsof the present disclosure.

FIGS. 7A and 7B show top and perspective views, respectively, of aclosure apparatus with rounded lateral edges and multi-layered mainpanels, according to embodiments of the present disclosure.

FIGS. 8A and 8B show top and perspective views, respectively, of aclosure apparatus having lateral ties with elastic or spring components,according to embodiments of the present disclosure.

FIGS. 9A, 9B, and 9C show perspective, top, and schematic views,respectively, of a closure apparatus having a central open wound orincision area and tie elements arranged circumferentially in anend-to-end loop surrounding the central open wound or incision area,according to embodiments of the present disclosure.

FIGS. 10A and 10B show perspective and top views, respectively, of aclosure apparatus having a central open wound or incision area and tieelements arranged radially about the central open wound or incisionarea, according to embodiments of the present disclosure.

FIGS. 11A and 11B show top views of a closure apparatus with and withouta casting sheet, respectively, having a central open wound or incisionarea of 5 centimeters or less and tie elements arranged so as to flankthe open wound or incision area, according to embodiments of the presentdisclosure.

FIGS. 12A and 12B show top views of a closure apparatus with and withouta casting sheet, respectively, having a central open wound or incisionarea of 2 centimeters or less and tie elements arranged so as to flankthe open wound or incision area, according to embodiments of the presentdisclosure.

FIGS. 13A and 13B show top views of a closure apparatus with and withouta casting sheet, respectively, having a central open would or incisionarea of 5 centimeters or less, elastic elements, and tie elementsarranged so as to flank the open wound or incision area, according toembodiments of the present disclosure.

FIGS. 14A and 14B show a top and side view, respectively, of a closureapparatus having a central open wound or incision area, a single closureelement, and opposing curved bases arranged so as to flank the openwound or incision area, according to embodiments of the presentdisclosure.

DETAILED DESCRIPTION

The following description may refer to the following terms which arefurther described as follows.

Arterial Skin Ulcer: Arterial skin ulcers account for up to 20% of allleg ulcers and develop when artery disease is present (sometimes incombination with venous disease). These ulcers tend to be extremelypainful and are usually on the toes and feet, where poorly functioningarteries are least likely to circulate blood. These types of ulcers aretypically caused by arteriosclerosis, which can lead to insufficientoxygenation of the skin and underlying tissues. This can kill theaffected tissues and cause wounds.

Clean wound (Class I). A Class I clean wound is a surgically createdwound, such as in an elective operating room (OR) case. Anothercondition to being a clean wound is that it does not involve therespiratory, gastrointestinal (GI), or GU (genitourinary) tracts.Laparoscopic surgeries, skin biopsies, and vascular surgeries are someexamples.

Clean contaminated wound (Class II). A Class II contaminated woundinvolves normal tissue that is colonized by bacteria. Wounds whichinvolve the respiratory, GI/GU tracts enter this category, as wouldwounds opened to remove pins or wires.

Closure by primary intention. Closure by primary intention is immediateclosure of a wound, using sutures, staples, surgical tape, or tissueadhesive glue. Typically, such closure is used for a clean orcontaminated wound after thorough cleansing and debridement.

Closure by secondary intention. Closure by secondary intention may allowa wound to heal naturally without any closure methods as above. This isthe usual strategy for badly contaminated wounds (such as animal bites)and infected wounds.

Closure by tertiary intention: see Delayed primary closure.

Contaminated wound (Class III). A Class III contaminated wound containsforeign or infected matter—the most typical situation seen in emergencydepartments. Gross contamination is not required to meet thisclassification, any contact with a foreign object like a bullet, knifeblade, or other sharp material may suffice.

Debridement. Debridement is the removal from tissue of allhyperkeratotic (thickened skin), infected, and nonviable includingnecrotic (dead) tissue, slough, foreign debris, and residual materialfrom dressings.

Delayed primary closure. Delayed primary closure is a strategy ofwaiting to close a wound after about 48 hours, after it has proven notto have any signs of infection. This is also sometimes referred to asClosure by tertiary intention. This is a strategy typically employed forclean contaminated wounds and clean wounds that are older than 6 hours.

Diabetic Foot Ulcer. Diabetic foot ulcers, also known as neuropathicskin ulcers, occur in people who have little or no sensation in theirfeet due to diabetic nerve damage. These skin ulcers develop at pressurepoints on the foot, such as on the heel, the great toe, or other spotsthat rub on footwear. Treatment cost per ulcer episode varies widelyaccording to ulcer depth, with an average cost estimated at $13,179.(Stockl K, Vanderplas A, Tafesse E, Chang E. Costs of lower-extremityulcers among patients with diabetes. Diabetes Care 2004; 27:2129-2134.)

Fasciotomy. Fasciotomy is the standard treatment for acute compartmentsyndrome (ACS). Historically, fasciotomy incisions were either left openor immediately closed; however, the rates of infections and recurrentcompartment syndrome were unacceptably high. In an attempt to improveoutcomes, there is a plethora of different wound closure techniquespublished, which includes immediate closure, delayed primary closure,and ultimately utilizing a skin graft to fill the void. Immediate ordelayed primary wound closure may help decrease the infection rates andimprove the cosmetic outcomes when compared with secondary closure andskin grafts. However, primary closure is not always possible, due totissue edema. (Jauregui J, et. al. Fasciotomy closure techniques: Ameta-analysis. 2017 Journal of Orthopedic Surgery, 25(1) 1-8.)

Infected (Class IV) wound. An infected (Class IV) wound is one withpurulent drainage. These include wounds with a foreign object lodged inthe wound like pieces of metal or other debris. This class can alsoinclude traumatic wounds from a dirty source where the treatment wasdelayed, infected surgical wounds, or any wound exposed to pus or fecalmatter.

Negative Pressure Wound Therapy (NPWT). NPWT typically involves theapplication of a therapeutic dressing typically comprising a wound pador sponge, an adhesive-backed occlusive sheet with a vacuum port, and avacuum (i.e., negative pressure) generating device.

Off-loading. Off-loading is the relieving of the pressure from theulcerated areas by having the patient wear special foot gear, a brace,specialized castings, or by using a wheelchair or crutches.

Pressure or Decubitus Ulcer: Pressure or decubitus ulcers or sores arelocalized areas of cellular necrosis resulting from prolonged pressurebetween any bony prominence and an external object such as a bed orwheelchair. The tissues are deprived of blood supply and eventually die.Areas frequently affected in older individuals include the heels (8%),greater trochanter (15%), sacrum (23%), and ischium (sit bones) (24%).They are common in bedridden individuals, especially the elderly. Olderindividuals with dementia are particularly prone.

Venous Skin Ulcers. Venous ulceration typically results from an elevatedambulatory venous pressure (venous hypertension). This frequently causesedema of the limb. External compression has been the mainstay to combatthese problems. It is the most common ulcer, accounting for up to 80% ofall leg ulcers. Chronic venous insufficiency can lead to venous stasisulceration, which may occur as a result of previous deep venousthrombosis. The basic dysfunction is incompetent valves of the deepveins. The ulcers usually develop around the ankles, especially in thearea of the medial malleoli. Loss of epidermis occurs, and portions ofthe dermal layer may also be involved, depending on the degree of venousstasis. A characteristic brownish coloration of the skin developsbecause of deposition of melanin and hemosiderin. When capillariesrupture, red blood cells are released and disintegrate, with subsequentrelease of hemosiderin.

The wound closure devices and their methods of use may be suitable forulcers and irregularly shaped wounds, examples of which are described inTable 1 as follows.

TABLE 1 Wound Type Standard of Care Gaps/Opportunities Diabetic FootWound cleansing, aseptic surgical Gentle, incremental external (i.e.,topical) Ulcer (DFU) debridement, hydrogel dressing into closure force,either standalone or in (The USA has the wound base covered by foamconjunction with other methods, may accelerate a population of dressing.wound closure/healing by increasing perfusion 18 million to wound.diabetics, with about 700,000 DFUs per year.) Venous Leg 25% closure at4 weeks, full closure Gentle, incremental external (i.e., topical) Ulcer(VLU) @ 16 weeks. closure force, either standalone or in (The USA hasExtrinsic compression to minimize conjunction with compressive sleeves,may occurrences of venous stasis, venous hypertension accelerate woundclosure/healing by increasing 2.2 million and edema. Newer methodsinclude perfusion to wound. VLUs per year, adding hydrocolloid dressingsto and VLUs compression. occur in 3.6% of those over 65 yrs old.)Dehisced Clean, debride, treat infection; then, Gentle, incrementalexternal (i.e., topical) Wound incrementally reclose with tensionclosure force may accelerate wound (Can be caused sutures or allowhealing by secondary closure/healing and result in a superior cosmeticby mechanical intention (granulation and scar. force (fall) orreepithelialization). infection.) Fasciotomy Success is defined as allwounds that Gentle, incremental external (i.e., topical) could be closedwithout skin grafting, closure force may accelerate wound amputation, ordeath. The highest closure/healing and result in a superior cosmeticsuccess rate was observed for scar. dynamic dermatotraction and gradualsuture approximation, whereas vacuum-assisted closure had the lowestcomplication rate. Pressure or Treatment depends on stage of ulcer.Gentle, incremental external (i.e., topical) Decubitus Mainly, offloadpressure, irrigation closure force, either standalone or in Ulcer anddressings; severe ulcers require conjunction with other methods, mayaccelerate debridement, antibiotics and wound closure/healing byincreasing perfusion reconstruction with grafts or flaps. to wound.

The need for tension-reduction during wound closure is currentlyaddressed by tension sutures or stretching devices designed to harnessthe viscoelastic properties of skin, applying controlled andevenly-distributed tension along the wound margins using incrementaltraction. The principle of stretching wound margins with tension suturesor commercially available devices may be problematic, as this techniquecan cause collateral skin damage, necrosis, and tear the skin marginsduring approximation of the opposing wound edges if excessive tension isapplied. Additionally, commercial devices may be invasive, bulky, andmay damage wound edges.

Delayed primary closure of surgical wounds or injuries may be used toaddress wound dehiscence, delayed closure after treatment ofcontaminated wounds (e.g., bullet and knife wounds), and incrementalclosure of fasciotomy. Currently, the inventors know of no dedicatedproducts for this, which leaves treatment to incrementally adjustedtension sutures or healing by secondary intention.

Diabetic foot ulcers (DFU) occur in at least 15 percent of all peoplewith diabetes mellitus and are the reason for approximately 20 percentof all hospitalizations of patients with diabetes. The most commoncauses of DFUs are diabetic peripheral neuropathy, existing footdeformity such as Charcot neuroarthropathy or partial footamputation(s), biomechanical abnormalities, and/or peripheral vasculardisease (PVD). Treatment focuses on healing by secondary intention andtypically includes debridement, systemic antibiotics, off-loading ofpressure from the area, creating and maintaining a clean, moist woundenvironment with specialized dressings and topically-appliedmedications. Newer approaches include negative pressure wound therapy(NPWT), which involves frequent specialized dressing changes and avacuum generator device tethered to the dressing.

Surgical wound closure that is at particularly high risk of dehiscencemay benefit from an adjunctive means of recruiting healthy tissueoutside of the immediate incision site to help offload force and bufferthe incision from any potential distraction force. Sternotomy is anexample of this, where the result of wound dehiscence is often fatal.

The present disclosure includes improved wound closure devices, systems,and their methods of use.

FIGS. 1A-1E show a closure apparatus 1 according to embodiments of thepresent disclosure. The closure apparatus 1 may comprise two base panels2 a, 2 b, coupled to one another by a plurality of reversibly adjustablelateral ties 4. Each base panel may comprise a bottom adhesive layer 13,a middle layer or main body 11, and a plurality of force distributionstructures 10 coupled to the top of the middle layer 11. Each layer maybe successively more rigid or less elastic from bottom to top, providinga vertical elasticity gradient, reducing adhesion loss and skinblistering when the skin upon which the closure apparatus is attached ismoved.

The bottom adhesive layer 13 may be covered by one or more removableliners. For example, there may be a central liner removable from a tabon one side of the closure apparatus 1 and a pair of side liners 12removable from tabs on the opposite side of the closure apparatus asshown in FIGS. 1A-1E, 3B, and 3C. Alternate liner configurations arealso envisioned, for example, liners covering the bottom whole of theeach of the base panels as shown in FIGS. 2A-2B, 4A-4B, 5A-5B, 6A-6B,and 7A-7B, or casting sheets covering the whole of the top each of thebase panels and liners covering the bottom whole of each of the basepanels as shown in FIGS. 11A-11B, 12A-12B, and 13A-13B. These liners 12may be peeled from tabs at their longitudinal and/or lateral ends. Ascan be seen in FIGS. 11A, 12A, 13A, and 14A, each of the base panels cancomprise a liner covering an adhesive layer and a casting sheet 16 whichcan removed from each of the top of the base panels. The casting sheetcan aid in the placement of each of the base panels. For example, thecasting sheet being adhered to each of the base panels can providerigidity and stability to the base panels, making them easier to handleand place. After placement, the casting sheet may be removed. The bottomadhesive layer 13 may comprise a hydrocolloid adhesive. The lateraledges of the liners and/or liner tabs may be flattened as in FIGS. 4A-4Band 5A-5B or may be rounded as in FIGS. 6A-6B, 7A-7B, 11A, 12A, and 13A.

The middle layer or main body 11 of the base panels may lie over thebottom adhesive layer 13. The middle layer or main body 11 of the basepanel may comprise a material such as a polymer material, such aspolyurethane. In some embodiments, the main body of the base panel maycomprise multiple, stepped layers as shown in FIGS. 5A-5B, FIGS. 7A-7B,and FIGS. 11A-11B. In some embodiments, the main body of the base panel2 a, 2 b may comprise multiple perforations 7 as shown in FIGS. 11A-11B,12A-12B, 13A-13B, and 14A. In some embodiments, the multipleperforations 7 are mirrored by perforations in the adhesive layer. Theperforations 7 can provide lateral stress relief for acute strain on thedevice. The perforations 7 can help protect skin to which the adhesiveis applied from acute lateral strain. For example, the perforations 7can accommodate the underlying skin stretching and contracting invarious direction by facilitating the stretching and contracting of thebase panels along with the skin, thereby reducing adhesion loss and/orlowering the risk of blistering from skin adhesion that may otherwise betoo strong.

Force distribution structures may be coupled to the top surfaces of thebase panels, and the ends of the lateral ties 4 may be coupled to theforce distribution structures to distribute the forces from theattachment of the wound closure apparatus to the skin as concentrated bythe attachment points of the lateral ties. For example, the lateral tiesmay have fixed ends 5 a at one base panel 2 a and adjustably coupledends 5 b at the other base panel 2 b with locks 6 as can be seen inFIGS. 1A-1E. The lateral ties may be coupled to the base panels 2 a, 2b, at a predetermined adjustable distance to provide a predeterminedlateral gap 8 between the inner lateral edges of the base panels, as canbe seen in FIGS. 1A-1B. The separation distance between the base panelsmay be large enough to encompass the most common ulcers. A suite ofclosure apparatuses, each with different sized lateral gaps 8 andseparation distances, may be provided. FIGS. 2A, 11A, 12A, and 13A showa top view of a wide closure apparatus and FIGS. 2B, 11B, 12B, and 13Bshow the wide closure apparatus with the release liner removed.

Alternatively or in combination, a suite of closure apparatus 1 withdifferent length base panels may be provided. The separation distancesmay be enlarged or reduced by adjusting the adjustable end of thelateral ties 5 b, and the separation distance may be adjusted to belarger or smaller at different lateral ties. The separation distance maystart, for example, at 10 mm or greater, 20 mm or greater, 30 mm orgreater, 40 mm or greater, or 50 mm or greater. The closure apparatusmay be configured to encompass and treat an ulcer or skin defect with aminor axis of at most 50 mm, 40 mm, 30 mm, at most 20 mm, or at most 10mm, for example. The lateral ties 4 will typically be more rigid thanthe middle layer or main body of the base panels and may comprise amaterial like nylon.

In some embodiments, particularly those with larger separation distancesas shown in FIGS. 8A, 8B, 13A and 13B, the lateral ties may be providedwith one or more spring or elastic components along their lengths and/orbe adjustable from either base. The spring or elastic component(s) 14may provide dimensional stability to the lateral ties 4, allowing somemovement of the lateral ties 4 relative to one another in directionstransverse to the length of the lateral ties 4 as well as along theirlengths while restricting too much movement. As shown in FIGS. 8A-8B and13A-13B, tie elements may have their fixed ends coupled to an elasticcomponent 14 positioned over the open wound or incision 15, while theadjustable ends 5 b are coupled to force distribution structures 3coupled to the upper surface of the middle, main layer 11 on theflanking base structures 2 a, 2 b. As shown in FIGS. 8A and 8B, thespring or elastic component(s) 14 may be in the form of a length ofrigid material having a serpentine configuration. As shown in FIGS. 13Aand 13B, the spring or elastic component(s) 14 may be in the form ofseparate units of rigid material between groupings of two lateral ties.The material may be similar or the same as that of the forcedistribution structure elements 3 and/or lateral ties 4, such as nylon.

The closure apparatus may share many features in common with the closureapparatuses described in U.S. patent applications: U.S. patentapplication Ser. No. 13/286,757 (now U.S. Pat. No. 8,323,313), Ser. Nos.13/665,160, 14/180,524 (U.S. Pat. No. 9,050,086), Ser. Nos. 14/180,564,14/625,366 (U.S. Pat. No. 9,642,621), Ser. No. 15/081,526 (U.S. Pat. No.9,474,529), Ser. No. 15/081,550 (U.S. Pat. No. 9,554,799), Ser. No.15/081,595 (U.S. Pat. No. 9,642,622), Ser. No. 15/096,083 (U.S. Pat. No.9,554,800), Ser. No. 15/130,149 (U.S. Pat. No. 9,561,034), and Ser. No.15/369,293, and PCT Application Nos. PCT/US2015/028066,PCT/US2016/028297, and PCT/US2017/028537, which are incorporated hereinby reference in its entirety.

FIGS. 3A-3F shows a method of applying a closure apparatus to a wound 15or skin defect SD. The ulcer or skin defect may be a diabetic footulcer, a venous leg ulcer, an arterial ulcer, a dehisced wound, adehisced infection, a fasciotomy, a pressure or decubitus ulcer, or abiopsy incision. As shown in FIG. 3B, the central liner 12 may beremoved by peeling the central liner away from the rest of the closureapparatus with the tab 19 of the central liner. With the adhesive layersof the closure apparatus exposed, the closure apparatus may bepositioned over the wound or skin defect SD to encompass the wound 15 orskin defect between the inner lateral edges of the base panels 2 a, 2 b,and the closure apparatus may be pressed against the skin adjacent thewound or skin defect SD to adhere the closure apparatus 1 thereto asshown in FIG. 3C. Subsequently, the two liners laterally adjacent thecentral liner may be peeled away to expose the rest of the adhesivelayers 13, and the closure apparatus 1 may be pressed against the skinto fully adhere the closure apparatus thereto as shown in FIG. 3D. Onceadhered, the lateral ties 4 may be adjusted and tightened to apply alateral compressive force to the wound or skin defect as shown in FIG.3E. In some cases, an additional wound closure apparatus may besimilarly applied over the wound or skin closure SD as shown in FIG. 3F.The additional wound closure apparatus may be placed in an orientationtransverse to the first wound closure apparatus as shown in FIG. 3F.Also, in some cases, a liquid glue, an anti-microbial agent, ananti-bacterial agent, and/or other therapeutic agent may be applied tothe wound or skin defect SD before, after, or during application of theone or more closure apparatuses.

Form factors for closure devices other than two parallel base panels arealso disclosed. Closure devices according to embodiments of the presentdisclosure may be in the form of a patch having a central wound orincision treatment aperture 20 that is open, as shown, for example, byFIGS. 9A-9C, 10A-10B, and 14A. As shown in FIGS. 9A-9C, 10A-10C, and14A, the closed shape closure device may be generally circular, ovoid,elliptical, or hexagonal, but may also be provided in other geometriessuch as a triangular, rectangular, square, pentagonal, or in the shapeof another polygon. The outer peripheral edge of the closed shapeclosure device may be scalloped or sinusoidal in shape to provideflexibility for the closure device in response to lateral forcesadjacent the closure device when adhered, thereby reducing the chance ofskin blistering and adhesion loss.

As shown in FIGS. 9A-9C, the closed shape closure device may comprise asingle base 9 with an adhesive bottom layer 13 and a middle, main layer11 similar to the adhesive bottom layers 13 and base panel main bodylayer 11 described above. A plurality of tie elements, similar to thelateral tie elements 4 described above, may be attached to forcedistribution elements 10 fixedly coupled to the upper surface of themiddle, main layer 11. The tie elements may be arrangedcircumferentially in an end-to-end loop surrounding the central openwound or incision area 22. Each tie element may comprise a fixed end 5 afixedly attached to its respective force distribution element and anadjustable end 5 b adjustably attached to its respective forcedistribution element. Fixed ends of each tie element may be immediatelyadjacent the adjustable ends of the next tie element over. As shown inFIGS. 9B and 9C, the tie elements may be reversibly tightened to shrinkthe central open wound or incision area and provide compressive force tothe area.

As shown in FIGS. 10A-10B and 14A, other arrangements of tie elementsfor the closed shape closure device are also provided. As shown in FIGS.10A-10B, tie elements may have their fixed ends coupled to a central hubstructure 21 positioned within the central open wound or incisiontreatment aperture 20, while the adjustable ends 5 b are coupled toforce distribution structures 3 coupled to the upper surface of themiddle, main layer 11 closer to the periphery of the closure device.This arrangement can leave the center of the hub structure 21 open andfree of any interfering structure such as the free ends of the tieelements. In other embodiments, the adjustable ends 5 b are coupled tothe central hub structure 21 and excess material can be simply cut orclipped away once adjusted as desired. The central hub structure 21 maybe made of the same material as the tie elements 4 and forcedistribution structures 10, such as nylon. As show in FIG. 14A, tieelements may be a single closure element 17 with a fixed end 18 acoupled to force distribution structures 10 coupled to the upper surfaceof a first base structure 2 a opposite a second base structure 2 b thatis coupled to the adjustable end 18 b of the closure element. The basestructures can be curved to form an oval shape, a circular shape, ahexagonal shape, a square shape, etc.

One or more of the components of the incision closure appliances orincision closure appliance assemblies disclosed herein, including one ormore of the various base assemblies, base panels, force distributionstructures, axial supports, lateral supports, closure components, tieassemblies, tie elements, straps, locks, adhesive layers, adhesivelayers, etc., may be comprised of, be coated with, or otherwiseincorporate one or more of an antifungal, antibacterial, antimicrobial,antiseptic, or medicated material. For example, such materials may beincorporated into the hydrocolloid adhesive layer, as another layer orcoating between the skin and the adhesive layer (covering at least aportion of the adhesive layer), incorporated into the base assemblycover or at least its adhesive layer, etc. One or more wells, grooves,openings, pores, or similar structures may be provided on the device orapparatus components to facilitate such incorporation. In manyembodiments, such materials may comprise one or more of silver, iodide,zinc, chlorine, copper, or natural materials such as tea tree oil as theactive agent. Examples of such antifungal, antibacterial, antimicrobial,antiseptic, or medicated materials include, but are not limited to, theActicoat™ family of materials available from Smith & Nephew plc of theU.K., the Acticoat™ Moisture Control family of materials available fromSmith & Nephew plc of the U.K., the Contreet™ Foam family of materialsavailable from Coloplast A/S of Denmark, the UrgoCell™ Silver family ofmaterials available from Urgo Limited of the U.K. (a subsidiary ofLaboratoires URGO of France), the Contreet™ Hydrocolloid family ofmaterials available from Smith & Nephew plc of the U.K., the Aquacel™ Agfamily of materials available from ConvaTec Inc. of Skillman, N.J., theSilvercel™ family of materials available from Kinetic Concepts, Inc. ofSan Antonio, Tex., Actisorb™ Silver 220 available from Kinetic Concepts,Inc. of San Antonio, Tex., the Urgotul™ SSD family of materialsavailable from Urgo Limited of the U.K. (a subsidiary of LaboratoiresURGO of France), the Inadine™ family of materials available from KineticConcepts, Inc. of San Antonio, Tex., the Iodoflex™ family of materialsavailable from Smith & Nephew plc of the U.K., the Sorbsan Silver™family of materials available from Aspen Medical Europe Ltd. of theU.K., the Polymem Silver™ family of materials available from Ferris Mfg.Corp. of Burr Ridge, Ill., the Promogram™ family of materials availablefrom Kinetic Concepts, Inc. of San Antonio, Tex., the Promogram Prisma™family of materials available from Kinetic Concepts, Inc. of SanAntonio, Tex., and the Arglaes™ family of materials available fromMedline Industries, Inc. of Mundelein, Ill. Components of the closuredevices described herein may be comprised of, be coated with, orotherwise incorporate one or more of an antifungal, antibacterial,antimicrobial, antiseptic, or medicated material, including but notlimited to one or more of the materials listed above.

In many embodiments, topical medicinal agents are incorporated directlyinto the wound closure appliances described herein. Because a woundclosure device is often applied in close proximity to a wound orincision in need of medicinal protection, the incorporation of suchmedicines directly into the closure device may be beneficial. In woundsat risk of infection, incorporation of anti-microbial agents may bebeneficial, for example. Anti-microbial agents may include antibioticmedicines as well as antiseptic metal ions and associated compoundswhich may include silver, iodine, copper, and chlorine, or naturalmaterials such as tea tree oil. In wounds prone to fungus, medicinalagents such as zinc may be warranted, for example. Combinations of anyof these agents may also be of benefit and thus may be incorporated intowound closure appliances.

Topical medicinal agents may be incorporated into the closure devices ina way to give the closure devices the ability to wick exudate away fromthe wound (e.g., to direct unwanted organisms away from the wound and/orprevent skin maceration), while keeping the wound sufficiently hydratedfor improved healing.

According to further aspects of the present disclosure, after assemblyof a closure device (such as closure apparatus 1) a coating can beapplied to the outer surface to prevent adhesion to the wound dressing.An exemplary coating may utilize a non-stick fluoropolymer coatingapplied and cured to the device 1, typically with a process that doesnot require temperatures exceeding 60° C. for 5 min., and morepreferably under 45° C. for any period of time. The adherence of thecoating with the polyurethane film of the wound closure device may bemost desired, though protection of all external surfaces may bedesirable as well. The fluoropolymer film thickness may range from 0.25to 5.0 microns, preferably about 1-3 microns. Coating would typicallytake place with release liners or other suitable material in contactwith the skin adhesive surface to prevent contamination of the skinadhesive with the coating. Such a coating would typically be applied aspart of the manufacturing process such that no additional coating isrequired to be applied by the user. However, in other embodiments, justbefore dressing application, the user may instead apply a preferablysterile oil-based liquid or gel to the outside of the closure apparatus1 to prevent adhesion. Examples include petrolatum and silicone oil.

Other coatings that do not require cure temperatures that can damage thedevice adhesives (typically above 60° C.) may be applied. These mayinclude silicone compounds or oils (cured to the material or uncured),parylene, and other coatings well-known in the art. The coating maypreferably remain bound to the closure device upon removal of thedressing, though could also act by deadening the applied adhesive,and/or acting as a sacrificial layer that is pulled up with the dressinginstead of the underlying device. Sacrificial coatings may be thicker,more in the range of 0.0005″-0.010″.

While preferable to apply to the entire finished device, the coatingcould be applied to selective regions of the device by masking areas tonot be coated. This may be useful if coating is incorporated into anintermediary process where component bonding must be subsequentlyperformed to non-coated regions of the device, or if coating of othercomponents (e.g., the locks and straps) results in undesirable lowfriction (e.g., straps don't stay engaged in locks or strap slips out ofuser's hands). In other cases, the coating may be on a material that isapplied separately to the device (e.g., a strip of polyurethane film).This may be useful if the coating process requires an elevatedtemperature or use of solvents that are incompatible with the rest ofthe device.

In other embodiments, the coating material may have an antimicrobialcompound incorporated into the coating. The coatings described above arepreferably conformal to the device surfaces and remains adhered to theclosure device at least until the wound dressing is applied. Thecoatings described also offer minimal resistance to closure devicestretch (up to 50%) and themselves do not loose protective effects whilethe dressing is worn against the closure device.

In other embodiments, an anti-microbial and/or a topical medicinal agentmay be applied to the wound or defect prior to, during, or afterapplication of the device to the skin. The anti-microbial and/or topicalmedicinal agent may be any of those mentioned herein.

While preferred embodiments of the present disclosure have been shownand described herein, it will be obvious to those skilled in the artthat such embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the present disclosure. It should beunderstood that various alternatives to the embodiments of the presentdisclosure described herein may be employed in practicing the inventionsof the present disclosure. It is intended that the following claimsdefine the scope of the invention and that methods and structures withinthe scope of these claims and their equivalents be covered thereby.

What is claimed is:
 1. A method for treating an ulcer or skin defect,the method comprising: adhering a first panel of a closure device toskin on a first side of an ulcer or skin defect; adhering a second panelof the closure device to skin on a second side of the ulcer or skindefect, wherein the first and second panels have a separation distancebetween inside lateral edges thereof, the separation distance being atleast 10 mm; and laterally compressing the ulcer or skin defect betweenthe first and second panels, thereby reducing the separation distancebetween the inside lateral edges of the first and second panels.
 2. Themethod of claim 1, wherein the ulcer or skin defect has a minor axis ofat most 50 mm.
 3. The method of claim 2, wherein the ulcer or skindefect has a minor axis of at most 40 mm.
 4. The method of claim 5,wherein the ulcer or skin defect has a minor axis of at most 30 mm. 5.The method of claim 4, wherein the ulcer or skin defect has a minor axisof at most 20 mm.
 6. The method of claim 5, wherein the ulcer or skindefect has a minor axis of at most 10 mm.
 7. The method of claim 1,wherein the separation distance between the inside lateral edges of thefirst and second panels prior to laterally compressing the ulcer or skindefect is at least 20 mm.
 8. The method of claim 7, wherein theseparation distance between the inside lateral edges of the first andsecond panels prior to laterally compressing the ulcer or skin defect isat least 30 mm.
 9. The method of claim 1, further comprising removingone or more liners from the closure device prior to adhering the firstand second panels to the skin.
 10. The method of claim 9, wherein theone or more liners are aligned in an orientation transverse tolongitudinal axes of the first and second panels.
 11. The method ofclaim 9, wherein removing the one or more liners comprises removing amiddle liner prior to adhering the closure device to the skin andremoving one or more further liners adjacent the middle liner.
 12. Themethod of claim 9, wherein removing the one or more liners comprisesremoving one or more liners adjacent a middle liner prior to adheringthe closure device to the skin and removing the middle liner.
 13. Themethod of claim 9, wherein removing the one or more liners comprisesremoving a first liner from the first base panel prior to adhering theclosure device to the skin and removing a second liner from the secondbase panel.
 14. The method of claim 1, wherein adhering the first andsecond panels to the skin comprises pressing adhesive bottom layers ofthe first and second panels against the skin.
 15. The method of claim14, wherein the adhesive bottom layers of the first and second panelscomprise hydrocolloid adhesive.
 16. The method of claim 15, wherein thefirst and second panels comprise base layers positioned over thehydrocolloid adhesives, the base layers being more rigid than thehydrocolloid adhesive.
 17. The method of claim 16, wherein the first andsecond panels each further comprise one or more force distributionstructures coupled to the base layers, the force distribution structuresbeing more rigid than the base layers.
 18. The method of claim 16,further comprising one or more lateral ties coupling the first andsecond base panels to one another.
 19. The method of claim 18, whereinthe one or more lateral ties are at least partially elastic.
 20. Themethod of claim 19, wherein the one or more lateral ties comprise anelastic or spring component.
 21. The method of claim 18, furthercomprising disengaging the one or more lateral ties from one or more ofthe first or second base panels to provide access to the ulcer or skindefect for care.
 22. The method of claim 21, further comprisingre-engaging the one or more lateral ties to the one or more of the firstor second base panels after the care.
 23. The method of claim 21,wherein the care comprises one or more of a cleaning, a debridement, anapplication of medication, an application of a skin substitute, anapplication of negative pressure, or an application of anoxygen-introducing apparatus to the ulcer or skin defect.
 24. The methodof claim 1, wherein laterally compressing the ulcer or skin defectcomprises adjusting one or more attachment points of one or more lateralties to the first or second panels.
 25. The method of claim 1, whereinthe ulcer or skin defect is a diabetic foot ulcer, a venous leg ulcer,an arterial ulcer, a dehisced wound, a dehisced infection, a fasciotomy,a pressure or decubitus ulcer, or a biopsy incision.
 26. The method ofclaim 1, wherein adhering the first and second panels of the closuredevice positions the closure device over the ulcer or skin defect in afirst orientation, and wherein the method further comprises positioninga second closure device over the ulcer or skin defect in a secondorientation different from the first orientation and adhering basepanels of the second closure device to the skin on third and fourthsides of the ulcer or skin defect.
 27. The method of claim 1, furthercomprising further reducing the separation distance between the insidelateral edges of the first and second panels after the ulcer or skindefect has at least partially healed.
 28. The method of claim 27,wherein further reducing the separation distance between the insidelateral edges of the first and second panels after the ulcer or skindefect has at least partially healed comprises incrementally tighteningone or more lateral ties coupling the first and second base panels toone another over a period of time to restore or increase a compressiveforce to promote healing of the ulcer or skin defect.
 29. The method ofclaim 1, wherein one or more of the first or second base panels has alateral elasticity gradient of increasing elasticity from an inner edgethereof to an outer edge thereof.
 30. The method of claim 29, whereinthe lateral elasticity gradient is provided by one or more ofoverlapping materials of different elasticity, stepped layers ofmaterial of a same elasticity, embossing, perforating, or patterningwith areas of no material to the one or more of the first or second basepanel.
 31. The method of claim 1, wherein one or more of the first orsecond base panels has a vertical elasticity gradient of increasingelasticity from an upper surface thereof to a bottom surface thereof.32. The method of claim 31, wherein the vertical elasticity gradient isprovided by vertically overlapping layers of different elasticity orthickness.
 33. The method of claim 1, wherein one or more of inner orouter edges of one or more of the first or second base panels issinusoidal or scalloped to minimize or distribute shear force orminimize skin blister formation.
 34. A closure device for treating anulcer or skin defect, the closure device comprising: a first panelhaving a first adhesive bottom surface for adhering to skin on a firstside of an ulcer or skin defect; a second panel having a second adhesivebottom surface for adhering to skin on a second side of the ulcer orskin defect, a plurality of lateral ties coupling the first and secondpanels to one another, the plurality of lateral ties maintaining aseparation distance of at least 10 mm between inside lateral edges ofthe first and second panels; and one or more liners coupled to the firstand second adhesive bottom surfaces.
 35. The device of claim 34, whereinthe separation distance is at least 20 mm.
 36. The device of claim 35,wherein the separation distance is at least 30 mm.
 37. The device ofclaim 36, wherein the separation distance is at least 40 mm.
 38. Thedevice of claim 37, wherein the separation distance is at least 50 mm.39. The device of claim 34, wherein the one or more liners are alignedin an orientation transverse to longitudinal axes of the first andsecond panels.
 40. The device of claim 39, wherein the one or moreliners comprise a middle liner prior and one or more further linersadjacent the middle liner.
 41. The device of claim 34, wherein the oneor more liners comprises a first liner removably coupled to the firstadhesive bottom layer of the first base panel prior and a second linerremovably coupled to the second adhesive bottom layer of the second basepanel.
 42. The device of claim 34, wherein the first and second adhesivebottom layers of the first and second panels comprise hydrocolloidadhesive.
 43. The device of claim 42, wherein the first and secondpanels comprise base layers positioned over the hydrocolloid adhesives,the base layers being more rigid than the hydrocolloid adhesive.
 44. Thedevice of claim 43, wherein the first and second panels each furthercomprise one or more force distribution structures coupled to the baselayers, the force distribution structures being more rigid than the baselayers.
 45. The device of claim 34, wherein the one or more lateral tiesare at least partially elastic.
 46. The device of claim 45, wherein theone or more lateral ties comprise an elastic or spring component. 47.The device of claim 45, wherein the one or more lateral ties are atleast partially disengagable and re-engagable to provide access to theulcer or skin defect for care.
 48. The device of claim 34, wherein theone or more lateral ties are at least partially adjustable to reduce theseparation distance between the inside lateral edges of the first andsecond panels and apply a compressive force to tissue therebetween whenthe device is adhered to skin.
 49. The device of claim 34, wherein oneor more of the first or second base panels has a lateral elasticitygradient of increasing elasticity from an inner edge thereof to an outeredge thereof.
 50. The device of claim 49, wherein the lateral elasticitygradient is provided by one or more of overlapping materials ofdifferent elasticity, stepped layers of material of a same elasticity,embossing, perforating, or patterning with areas of no material to theone or more of the first or second base panel.
 51. The device of claim34, wherein one or more of the first or second base panels has avertical elasticity gradient of increasing elasticity from an uppersurface thereof to a bottom surface thereof.
 52. The device of claim 51,wherein the vertical elasticity gradient is provided by verticallyoverlapping layers of different elasticity or thickness.
 53. The deviceof claim 34, wherein one or more of inner or outer edges of one or moreof the first or second base panels is sinusoidal or scalloped tominimize or distribute shear force or minimize skin blister formation.54. A closure device for treating an ulcer or skin defect, the closuredevice comprising: an adhesive bottom layer; a base layer; a pluralityof supports coupled to the base layer; and a plurality of adjustableties coupled to the plurality of supports, wherein the adhesive bottomlayer and the base layer define a central treatment aperture toaccommodate the ulcer or skin defect, and wherein the plurality ofadjustable ties are adjustable to reduce an area of the centraltreatment aperture and apply a compressive force tissue encompassed bythe central treatment aperture thereby.
 55. The device of claim 54,wherein each lateral tie comprises a fixed end and an adjustable end.56. The device of claim 55, wherein the lateral ties are arrangedend-to-end along a periphery of the closure device.
 57. The device ofclaim 56, wherein fixed ends of the lateral ties are adjacent adjustableends of the lateral ties.
 58. The device of claim 55, further comprisinga central hub structure.
 59. The device of claim 58, wherein the fixedends of the lateral ties are coupled to the central hub structure andthe adjustable ends of the lateral ties are coupled to the supportscoupled to the base layer.
 60. The device of claim 54, wherein thebottom layer comprises a hydrocolloid adhesive.
 61. The device of claim60, wherein the main layer is positioned over the hydrocolloid adhesiveand is more rigid than the hydrocolloid adhesive.
 62. The device ofclaim 61, wherein the plurality of supports is more rigid than the baselayers.
 63. The device of claim 54, wherein the one or more lateral tiesare at least partially disengagable and re-engagable.
 64. The device ofclaim 54, wherein the device has a lateral elasticity gradient ofincreasing elasticity from an inner edge thereof to an outer edgethereof.
 65. The device of claim 64, wherein the lateral elasticitygradient is provided by one or more of overlapping materials ofdifferent elasticity, stepped layers of material of a same elasticity,embossing, perforating, or patterning with areas of no material to theone or more of the first or second base panel.
 66. The device of claim54, wherein the device has a vertical elasticity gradient of increasingelasticity from an upper surface thereof to a bottom surface thereof.67. The device of claim 66, wherein the vertical elasticity gradient isprovided by vertically overlapping layers of different elasticity orthickness.
 68. The device of claim 54, wherein one or more of inner orouter edges of one or more of the first or second base panels issinusoidal or scalloped to minimize or distribute shear force orminimize skin blister formation.
 69. The device of claim 54, wherein thedevice has a triangular, rectangular, square, pentagonal, hexagonal, orother polygonal outer shape.
 70. A method for treating an ulcer or skindefect, the method comprising: positioning a closure device over theulcer or skin defect so that the ulcer or skin defect is encompassed bythe central treatment aperture of the closure device; adhering theclosure device to skin around the ulcer or skin defect; and tighteningone or more adjustable ties of the closure device to apply a compressiveforce to tissue to tissue around the ulcer or skin defect encompassed bythe central treatment aperture.
 71. The method of claim 70, wherein eachlateral tie comprises a fixed end and an adjustable end.
 72. The methodof claim 71, wherein the lateral ties are arranged end-to-end along aperiphery of the closure device.
 73. The method of claim 72, whereinfixed ends of the lateral ties are adjacent adjustable ends of thelateral ties.
 74. The method of claim 71, wherein the closure devicefurther comprises a central hub structure.
 75. The method of claim 74,wherein the fixed ends of the lateral ties are coupled to the centralhub structure and the adjustable ends of the lateral ties are coupled tothe supports coupled to the base layer.
 76. The method of claim 70,wherein the ulcer or skin defect is a diabetic foot ulcer, a venous legulcer, an arterial ulcer, a dehisced wound, a dehisced infection, afasciotomy, a pressure or decubitus ulcer, or a biopsy incision.
 77. Themethod of claim 70, wherein the ulcer or skin defect has a minor axis ofat most 30 mm.
 78. The method of claim 77, wherein the ulcer or skindefect has a minor axis of at most 20 mm.
 79. The method of claim 78,wherein the ulcer or skin defect has a minor axis of at most 10 mm.